MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 06/20/2020

Event Type  Death  

Manufacturer Narrative

The patient reported age of 50 is representative of the mean patient age for all patients included in the literature article study and not necessarily representative of the patient in this report.The reported patient gender of "male" is representative of the majority of patient in the literature article study (52%) and not necessarily representative of the patient in this report.The patient race "white" is representative of the majority of patients in the literature article study (72%) and not necessarily representative of the patient in this report.If information is provided in the future, a supplemental report will be issued.

Event Description

Griffin, a., lerner, e., zuchowski, a., zomorodi, a., gonzalez, l.F., hauch, e.F.(2020).Flow diversion of fusiform intracranial aneurysms.Neurosurgical review.Https://doi.Org/10.1007/s10142-020-01332-0 abstract fusiform aneurysms are less common than saccular aneurysms, but have higher associated mortality and rebleeding rates.Recently, flow diversion has emerged as a possible treatment option.The purpose of this study was to determine the safety and efficacy of the pipeline embolization device (ped) for the treatment of ruptured and unruptured fusiform aneurysms.This was a retrospective analysis of patients with fusiform intracranial aneurysms treated with a ped at a quaternary care center between january 2012 and september 2019.Occlusion rates, neurologic morbidity/mortality, and other clinical variables were analyzed.Twenty-nine patients with 30 fusiform aneurysms were treated with a ped.Sixteen aneurysms (53%) were located in the anterior circulation and 14 aneurysms (47%) were in the posterior circulation.The mean maximal diameter of the aneurysms was 10.1 ± 5.6 mm (range 2.3¿25 mm).Angiographic and clinical follow-up were available for 28 aneurysms (93%).The median follow-up was 17.4 months (iqr 4.8 to 28 months) and occlusion rates were graded according to the o¿kelly-marotta (okm) scale.Of patients with dsa follow-up, 15 aneurysms (60%) were completely occluded (okm d) and 19 aneurysms (76%) had a favorable occlusion result (okm c1-3 and d).The overall complication rate was 26.7% with a neurological morbidity rate of 6.7% and neurological mortality rate of 3.4%.Flow diversion can be an effective treatment for both ruptured and unruptured fusiform aneurysms.Nevertheless, complete occlusion rates are lower than for saccular aneurysms.Therefore, flow diversion should be considered only if other more direct treatment options, such as clipping or stent/coiling are not applicable.Flow diversion should be used cautiously in patients presenting with rupture.It was reported that all procedures in the study were technically successful.No device malfunctions were reported.One patient suffered brainstem stroke due to acute thrombosis.This required tracheostomy and percutaneous gastrostomy tube placement.The patient died 1.5 years later and the patient's cause of death was noted to be sepsis related to pneumonia.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11002677
• MDR Text Key: 221270966
• Report Number: 2029214-2020-01296
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-RPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 50 YR